Hindustan Antibiotics (HA) Ltd has stopped production of saline bottles following directives from the Food and Drug Administration (FDA) which described HA’s claim of a labelling goof-up as gross negligence on the part of the company.
We stalled the production after receiving a notice from FDA on Friday to do so till the issue is resolved, HA personnel manager T Das told this paper on Tuesday. FDA officials said they had collected samples of the saline bottles from the company premises and had sent them for testing to the drug laboratory in Mumbai. Prima facie it looks like a labelling error,but we want HA to wait till the laboratory report is available, senior FDA officials said.
Last week,FDA joint commissioner B R Masal had told this paper that the saline bottles contain 0.9 per cent sodium chloride. However,the label stated 5 per cent extra dextrose in Hindi. We inspected the company premises on July 11 and July 12 and took samples of eight batches, said Masal.
Das said the company produces 40,000 saline bottles daily. In the last four days,there has been a loss of 1.60 lakh bottles. Each bottle is worth Rs 8.40, said Das. Company officials said so far there has been a turnover loss of Rs 12 lakh and this will continue till the FDA lifts its production ban. Due to closure of saline bottle production,HA has now shifted 40 employees to other sections.
HA officials are confident that the laboratory report will be in their favour. It was only a labelling error. We are sure the laboratory report will confirm our views, Das said. HA has charge-sheeted three senior officials in connection with the incident and a contractor has been served a notice. The three officials were apparently responsible for ensuring that appropriate labels are put on bottles.
HA had withdrawn as many as 1.03 lakh saline bottles after the labelling error came to light. The saline bottles were supplied to a government hospital in Jaipur. HA officials said the bottles were not marketed in Pune.
HA officials have called the incident a big embarrassment since it had come at a time when the company was trying to wriggle out of a bad phase. We will take stern action against the officials involved. This should not have happened as we had picked up pace after a slowdown for some years, senior officials said.